DEFINE AFib (Atrial Fibrillation)
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT04926857
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Brief Summary
DEFINE AFib is a prospective, observational, post-market clinical study administered to patients via the Medtronic Discovery app platform. This study will enroll approximately 5,000 patients in the United States who have a Reveal LINQ or LINQ II ICM (or future market-released LINQ devices) and an Apple® iPhone® with iOS version 13 or higher. Interested participants will be screened through the Medtronic Discovery app and those eligible will complete an app-based informed consent. Participants will receive health-focused and quality of life surveys at variable timepoints. DEFINE AFib will measure healthcare interactions using administered surveys to identify said interactions. The Medtronic Discovery app will provide participants with a summary of their ICM data. Participants will be followed up to 5 years or to the end of their ICM service life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 973
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Healthcare Utilization where AF was a reason or a suspected reason for the healthcare interaction. Through study completion (2 years of enrollment, up to 5 years of follow-up) Primary objective is to evaluate whether summary and episodic measurements collected by market-released LINQ ICMs are able to predict increased AF-related healthcare utilization (HCU), which are confirmed healthcare visits in the inpatient hospital, outpatient hospital, clinic/office, emergency department, or other care location (including remote visits) where AF was a reason or suspected reason for healthcare interaction.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
Cone Health
🇺🇸Greensboro, North Carolina, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Stormont Vail Health Cotton O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
Saint Joseph Heritage Hospital
🇺🇸Mission Viejo, California, United States
Desert Heart Rhythm Consultants
🇺🇸Palm Springs, California, United States
Cardiac Arrhythmia Service
🇺🇸Boca Raton, Florida, United States
Florida Electrophysiology Associates
🇺🇸Atlantis, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
HCA Healthcare
🇺🇸Overland Park, Kansas, United States
Jackson Heart Clinic
🇺🇸Jackson, Mississippi, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
New York Presbyterian Brooklyn Methodist Hospital
🇺🇸Brooklyn, New York, United States
NYU Langone Hospital Long Island
🇺🇸Mineola, New York, United States
White Plains Hospital Medical Center
🇺🇸White Plains, New York, United States
Huntington Hospital
🇺🇸Huntington, New York, United States
Stern Cardiovascular Foundation
🇺🇸Germantown, Tennessee, United States
St. Luke's Cardiology Associates
🇺🇸Bethlehem, Pennsylvania, United States
PeaceHealth Saint Joseph Medical Center
🇺🇸Bellingham, Washington, United States
Norton Heart Specialists
🇺🇸Louisville, Kentucky, United States
Oklahoma Heart Hospital Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Florida Health Shands Hospital
🇺🇸Gainesville, Florida, United States
Ascension Seton Heart Institute Clinical Research
🇺🇸Austin, Texas, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States